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Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
Sponsor: Replimune Inc.
Summary
The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
Official title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors [IGNYTE]
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2017-09-20
Completion Date
2028-12
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
Locations (51)
University of Birmingham Alabama
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California- San Francisco
San Francisco, California, United States
Sylvester Comprehensive Cancer Center- University of Miami
Miami, Florida, United States
University of Iowa-Cancer Center Research
Iowa City, Iowa, United States
James Graham Brown Cancer Center- University of Louisville
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University Clinical Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
MUSC Health
Charleston, South Carolina, United States
West Cancer Center
Germantown, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Eccles Outpatient Care Center- Oncology Clinical Trials
Murray, Utah, United States
Intermountain Cancer Center- Saint George Cancer Center
St. George, Utah, United States
Seattle Cancer Care Alliance- University of Washington
Seattle, Washington, United States
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, United States
CHU Besancon - Hopital Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
CHU Dijon
Dijon, France
Centre Léon Bérard Lyon
Lyon, France
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
Marseille, France
CHU de Nice Hôpital l'Archet
Nice, France
Hôpital Saint Louis APHP
Paris, France
Institut Gustave Roussy
Villejuif, France
Charité (Campus Benjamin Franklin)
Berlin, Germany
University Hospital Essen, Klinik für Dermatologie
Essen, Germany
University of Kiel (UKSH), Dep. of Dermatology
Kiel, Germany
Uniklinik Marburg
Marburg, Germany
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Clínica Universidad de Navarra (Madrid)
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital General Universitario de Valencia
Valencia, Spain
University of Leeds- Teaching Hospital
Leeds, England, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
Beatson West of Scotland Cancer Center
Glasgow, Scotland, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom